Scientist, UpstreamCell Culture

Job Description Summary

Job Description

Key Responsibilities

• Leads and support activity with cross-functional organizations to plan execute and document experiments and early manufacturing that define the process and method of delivery to the clinical and commercial sites.
• Design and execution of time-sensitive experiments studies and capturing related data and knowledge to advance the development products from Research to Development to GMP manufacturing.
• Maintains constant awareness of novel biochemical and biophysical technologies for gene therapy production and characterization. Keeps up to date with the scientific literature and developments in the field. Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments. Justifies development strategies and experiment designs.
• Designs and applies DOE and QbD studies to develop refine optimize and characterize cell culture and vector production processes. Executes experiments and troubleshoot process and equipment. Conducts laboratory studies to enhance gene therapy manufacturing technologies capabilities and processes (such as media development bioreactor fed-batch and perfusion process development optimization and scale-up).
• Supports initiatives for new technology development and continuous improvement projects.
• Provides support for process analytical and characterization knowledge related to the production of gene therapy products and the raw materials needed to make them.
• Tracks records of collaborative relations with groups such as research and development analytical development and pilot scale operations.
• Ensures all documentation and reports are accurate complete and suitable for using in support of production characterization and regulatory filings.
• Writes detailed experimental protocols develop Bill of Materials (BOM) executes and documents experimental studies according to Standard Operating Procedures (SOPs) or established practices review and report data.
• Creates and revise SOPs for equipment and process operations.
• Lead the authoring of technical reports and CMC sections for regulatory filings.

Essential Requirements:

• Bachelors degree in biochemistry chemical engineering bioengineering or related technical field with 4 years relevant experience; or Masters with 2 years relevant experience; or PhD with academic experience (Recent PhD welcome to apply).
• Extensive experience with production of virus or biologics from mammalian expression systems.
• Hands on experience with different cell lines bioreactors and scale-down model
• Organized and systematic approach to viral or biologic production.
• Ability to multi-task and meet tight timelines is essential.
• Proficient in statistical analysis principles and approaches. Working knowledge and experience with Design of Experiment (DoE).
• Ability to analyze data to make date-driven decisions and further progress development strategies. Innovative with a continuous improvement mindset. Excellent team player with good
• communication skills.
• Excellent team player with good communication skills.

Desired Requirements

• Knowledge with a variety of biopharmaceutical purification processes is desired
• Knowledge of viral cell/gene therapy and previous experience with LVV process development is preferred.

The salary for this position is expected to range between $93800 and $174200 per year.

The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired